CAMBRIDGE, Mass.--(BUSINESS WIRE)--Mar. 6, 2015--
AVEO Oncology (NASDAQ:AVEO) today announced the presentation of final
results, including a predefined biomarker analysis, from the BATON- (Biomarker
Assessment of Tivozanib
in ONcology) CRC study, a randomized Phase
2 clinical trial of modified FOLFOX6 combined with tivozanib or
bevacizumab in metastatic colorectal cancer (CRC). The presentation,
titled “Neuropilin-1 as a potential biomarker of progression-free
survival benefit for tivozanib + mFOLFOX6 versus bevacizumab + mFOLFOX6
in metastatic colorectal cancer: post-hoc biomarker analysis of
BATON-CRC Phase 2 trial,” will be presented in a poster session today at
the American Association for Cancer Research (AACR) Tumor Angiogenesis
and Vascular Normalization Conference, taking place March 5-8, 2015, in
Orlando, FL. Tivozanib is an oral, potent, selective inhibitor of
vascular endothelial growth factor (VEGF) with a long half-life and
activity against all three VEGF receptors.

The BATON-CRC study enrolled a total of 265 patients randomized 2 to 1
to receive tivozanib in combination with mFOLFOX6 (n=177) compared to
bevacizumab and mFOLFOX6 (n=88) as first-line treatment in patients with
advanced metastatic CRC. A key objective of the BATON-CRC study is the
assessment of prospectively defined biomarkers that may be predictive of
response in selected patient subpopulations. Among these, patients with
low neuropilin-1 (NRP-1) showed an improved progression free survival
(PFS) versus patients with high NRP-1 in both treatment arms, supporting
the value of NRP-1 as a potential prognostic marker for angiogenesis
inhibitors. Further, patients with serum NRP-1 levels below the median
demonstrated longer PFS when treated with tivozanib (17.9 months, n=52),
compared to bevacizumab (11.2 months, n=28) (HR=0.380, p=0.0075),
suggesting NRP-1 may have potential as a predictive biomarker of
tivozanib activity relative to bevacizumab. Patients with high serum
NRP-1 had PFS of 7.3 months and 7.5 months for the tivozanib and
bevacizumab arms, respectively. With only 21 deaths in the NRP-1 low
group upon study termination, no conclusion could be reached in an
analysis of overall survival.

An earlier, pre-specified interim futility analysis determined that
tivozanib was unlikely to demonstrate superiority to bevacizumab in the
primary endpoint of PFS in the intent to treat population (ESMO 2014),
resulting in discontinuation of the study. The results presented today
are the final results, and include five additional months of study
conduct and patient follow-up beyond the data cutoff for the interim
futility analysis. In the intent to treat population, the tivozanib and
bevacizumab combinations demonstrated comparable results for PFS, the
primary endpoint (9.8 months and 9.5 months for tivozanib and
bevacizumab, respectively, HR=0.908, p=0.598), and overall response rate
(46.9% and 43.2%, for tivozanib and bevacizumab, respectively), while
demonstrating comparable safety. The most common toxicities included
diarrhea, nausea, fatigue, neutropenia and hypertension. Serious adverse
events were reported for 46.3% of patients in the tivozanib group and
48.3% in the bevacizumab group.

“Where NRP-1 expression is low, the tumor appears to rely more heavily
on the VEGF pathway and become more susceptible to anti-VEGF therapies,
such as bevacizumab or tivozanib, an observation seen across several
tumor types, including breast, gastric, colorectal and renal cell
cancers,” said Al B. Benson III, MD, FACP, Professor of Medicine at the
Feinberg School of Medicine, Associate Director for Clinical
Investigations at the Robert H. Lurie Comprehensive Cancer Center of
Northwestern University, and principal investigator of the study.
“Results from the BATON-CRC study are consistent with these
observations. Further, the increase in PFS for patients treated with
tivozanib compared to bevacizumab is both interesting and encouraging. I
believe that these findings warrant further study in a prospectively
defined trial of patients with low serum NRP-1 metastatic colorectal
cancer.”

“These results underscore tivozanib’s activity and differentiating
properties, including the potential benefit of a more complete
anti-angiogenesis blockade in selected patient populations,” said
Michael Needle, MD, chief medical officer of AVEO. “We believe these
data suggest a promising new development path forward in a significant
patient population.”

The AVEO management team will host a conference call today, March 6, at
8:00 am (ET). The call can be accessed by dialing 1-877-280-4954
(domestic) or 1-857-244-7311 (international) five minutes prior to the
start of the call and providing the passcode 38640881. A replay of the
call will be available two hours after the completion of the call and
can be accessed by dialing 1-888-286-8010 (domestic) or 1-617-801-6888
(international), providing the passcode 54500453. The replay will be
available for two weeks from the date of the live call.

The live webcast of the conference call can be accessed by visiting the
investors section of the AVEO website at www.aveooncology.com.
A replay of the webcast will be archived on the AVEO website for two
weeks following the call.

About Colorectal Cancer

The American Cancer Society estimates that more than 130,000 men and
women in the United States will be diagnosed with colorectal cancer
(CRC) and nearly 50,000 will die of the disease in the United States in
2015.1 CRC is the third most commonly diagnosed cancer in
both men and women and the third leading cause of cancer death in the
United States. In Europe, it is estimated that almost 180,000 men and
women are diagnosed with CRC and that nearly 80,000 die from the disease
each year.2

About Tivozanib

Tivozanib is an oral, once-daily, investigational vascular endothelial
growth factor (VEGF) tyrosine kinase inhibitor (TKI). It is a potent,
selective and long half-life inhibitor of all three VEGF receptors and
is designed to optimize VEGF blockade while minimizing off-target
toxicities, potentially resulting in improved efficacy and minimal dose
modifications. Tivozanib has been evaluated in several tumors types,
including renal cell, colorectal and breast cancers.

About AVEO

AVEO Oncology (NASDAQ:AVEO) is a biopharmaceutical company committed to
developing targeted therapies through biomarker-driven insights to
provide improvements in patient outcomes where significant unmet medical
needs exist. AVEO’s proprietary Human Response Platform™ has delivered
unique insights into cancer and related disease biology that AVEO is
seeking to leverage in the clinical development strategy of its
therapeutic candidates. For more information, please visit the company’s
website at www.aveooncology.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements of AVEO within
the meaning of The Private Securities Litigation Reform Act of 1995 that
involve substantial risks and uncertainties. All statements, other than
statements of historical facts, contained in this press release are
forward-looking statements. The words “anticipate,” “believe,”
“estimate,” “expect,” “intend,” “may,” “plan,” “target,” “potential,”
“could,” “should,” “seek,” or the negative of these terms or other
similar expressions, are intended to identify forward-looking
statements, although not all forward-looking statements contain these
identifying words. These forward-looking statements include, among
others, statements about potential strategic options for the development
of tivozanib and the expected beneficial properties of tivozanib,
including its potential to provide a more complete anti-angiogenesis
blockade. Actual results or events could differ materially from the
plans, intentions and expectations disclosed in the forward-looking
statements that AVEO makes due to a number of important factors,
including risks relating to: AVEO’s ability to execute on its business
strategy, including its ability to enter into and maintain new strategic
partnerships and collaboration agreements; AVEO’s ability to
successfully enroll and complete clinical trials and preclinical studies
of its product candidates; AVEO’s ability to demonstrate to the
satisfaction of the FDA, EMA or other equivalent foreign regulatory
agencies, the safety, efficacy and clinically meaningful benefit of its
product candidates; AVEO’s ability to demonstrate in later clinical
trials positive results that may be observed in earlier-stage clinical
trials; AVEO’s ability to achieve and maintain compliance with all
regulatory requirements applicable to its product candidates; AVEO’s
ability to obtain and maintain adequate protection for intellectual
property rights relating to its product candidates and technologies;
developments and expenses related to AVEO’s ongoing shareholder
litigation and SEC inquiry; AVEO’s ability to raise the substantial
additional funds required to achieve its goals; adverse general economic
and industry conditions; competitive factors; and those risks discussed
in the section titled “Risk Factors” included in AVEO’s most recent
Annual Report on Form 10-K, its quarterly reports on Form 10-Q and in
its other filings with the SEC. The forward-looking statements in this
press release represent AVEO’s views as of the date of this press
release. AVEO anticipates that subsequent events and developments will
cause its views to change. However, while AVEO may elect to update these
forward-looking statements at some point in the future, it specifically
disclaims any obligation to do so. You should, therefore, not rely on
these forward-looking statements as representing AVEO’s views as of any
date subsequent to the date of this press release.